Methods and apparatus for human anatomical orthoses

ABSTRACT

Methods and apparatus for human anatomical orthoses. In one embodiment, an orthoses is disclosed that has been integrated into a sock and includes a tensioning element that is configured to keep the top portion of the sock at or above a user&#39;s calf muscle, a rotary tensioning mechanism disposed adjacent to the top portion of the sock, a support cable that is weaved within the body of the sock such that the support cable is maintained in close proximity with a user&#39;s leg when tension is applied thereto, and a supporting structure that is coupled to the support cable, the supporting structure being disposed adjacent to a user&#39;s toes. Methods of manufacturing and using the aforementioned orthoses is also disclosed.

PRIORITY

This application claims the benefit of priority to both co-owned andco-pending U.S. Provisional Patent Application Ser. No. 62/505,740 filedMay 12, 2017 of the same title and U.S. Provisional Patent ApplicationSer. No. 62/625,893 filed Feb. 2, 2018, the contents of each of theforegoing being incorporated herein by reference in its entirety.

COPYRIGHT

A portion of the disclosure of this patent document contains materialthat is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in the Patent and TrademarkOffice patent files or records, but otherwise reserves all copyrightrights whatsoever.

BACKGROUND OF THE DISCLOSURE Field of the disclosure

The present disclosure relates generally to the field of the correctionof disorders of the limbs or spine by use of braces and other devices tocorrect alignment or provide support and in one exemplary aspect, tofoot and ankle orthoses and methods for manufacturing and using thesame.

Description of Related Art

Drop foot is a common medical condition that has its source in variousdifferent pathological conditions. The condition may be caused by traumain which the peroneal nerve that innervates the peroneal muscles becomesdamaged. Drop foot may also be present following a stroke, or it may becongenital. Many orthotic treatments exist for the treatment of dropfoot including, for example: rigid ankle foot orthoses (AFOs);semi-rigid foot orthoses; soft AFOs (such as “Foot Up”-type devices or asoft ankle brace with straps); and functional electrical stimulationsystems.

The primary goal for each of these solutions is in the prevention ofplantar flexion of the foot during swing phase, as well as reducing footslap during heel strike. Considerations that these devices try to takeinto account are one or more of: (1) improved overall stability of theankle; (2) the devices ease of use (i.e., easy to put on or take off);(3) the devices are comfortable to wear; (4) the devices areaesthetically pleasing in appearance; and/or (5) the devices are easy towear with shoes. Unfortunately while these devices try to maximize oneor more of the benefits listed above, most fail at achieving all ofthese items, or are otherwise sub-optimal in one or more of these areas.For example, typical complaints by patients with a drop foot conditionthat are mentioned when utilizing these prior orthopedic devices are:(1) the device is uncomfortable to wear; (2) the device is difficult tointegrate into a standard shoe; (3) the device is too big and bulky; (4)the device typically needs to be worn with a specially designed shoe,which isn't always appropriate in all circumstances (e.g., when wearingthe device at home); and (5) the device does not provide the properamount of immobilization (i.e., too much or too little support) foreveryday usage.

In recent years, there have been two (2) main types of devices whichhave particularly tried to tackle these five (5) common complaints;however these devices have not managed to solve these problems, or otherproblems have arisen as a result of their designs. One such type ofdevice is a functional electrical stimulation device. While functionalelectrical stimulation devices are promoted as providing stability onlywhen you need it; being low profile and generally easy to hide; aregenerally easy to put on and take off; and can be worn with or withoutshoes, these types of devices aren't without their drawbacks. Forexample, often times these functional electrical stimulation devices canbe uncomfortable to wear; don't always work; and are relativelyexpensive. Another type of device are so-called “Foot Up” types ofdevices, that typically include a soft ankle strap that connects to ashoe or a foot strap. These types of devices are typically low profileand easy to hide; are easy to put on and take off; and are generallycomfortable. However, these types of devices are not very aestheticallypleasing; offer poor support (e.g., the device slips down on a user'sankle and otherwise loses its ability to provide a supporting function);and preferably need to be worn with shoes.

Accordingly, despite the wide variety of the foregoing solutions, thereremains a salient need for an orthotic device that: provides adequatesupport for everyday use; is comfortable to wear; is inexpensive; iseasy to put on and take off; can be worn with and without shoes; andfits well with existing clothing.

SUMMARY

The present disclosure satisfies the foregoing needs by providing, interalia, an orthoses apparatus for addressing each of the foregoingdesirable traits as well as methods of their manufacture and methods oftheir use.

In one aspect of the present disclosure, an orthoses is disclosed. Inone embodiment, the orthoses has been integrated into a sock andincludes a tensioning element that is configured to keep the top portionof the sock at or above a user's calf muscle, a rotary tensioningmechanism disposed adjacent to the top portion of the sock, a supportcable that is weaved within the body of the sock such that the supportcable is maintained in close proximity with a user's leg when tension isapplied thereto, and a supporting structure that is coupled to thesupport cable, the supporting structure being disposed adjacent to auser's toes.

In another embodiment, the orthoses may be configured for positioningaround a joint of, for example, a human body. The orthoses may furtherinclude a tensioning element that is configured to apply flexion to thejoint. In one variant, instead of applying flexion to the joint, thetensioning element may be configured to apply extension to the joint. Insome variants, the joint may be one or more of joints on an arm (e.g.,elbow, wrist, etc.), shoulder, and knee.

In another embodiment, the orthoses includes a foot ankle orthoses. Inone variant, the foot ankle orthoses includes a sock that is configuredto fit over a calf muscle on a leg of a user; and a compression strapsystem that includes: an upper retention structure that is configured tobe positioned above the calf muscle of the user when disposed on the legof the user, the upper retention structure including a first structurethat is spaced circumferentially from a second structure; an ankleretention structure that is configured to be positioned around an ankleof the user and below the calf muscle of the user; a foot retentionstructure that is configured to be positioned proximate a ball of a footof a user; and a support element that is operatively coupled with thefirst structure, the second structure, the ankle retention structure,and the foot retention structure. The upper retention structure isconfigured to tighten around an anatomy of the user when the sock movesinto a plantar flexed position via application of tension between thefirst structure and the second structure.

In another variant, the ankle retention structure includes: an upperankle retention structure that is configured to be positioned above theankle of the user and below the calf muscle of the user; and a lowerankle retention structure that is configured to be positioned below theankle of the user at a transition point between a heel of the user and amidfoot of the user.

In yet another variant, the support element includes one or more of asupport strap or a support cable.

In yet another variant, an adjustable tensioning mechanism is disclosedthat is disposed at an upper portion of the sock, the adjustabletensioning mechanism configured to tension the support strap or thesupport cable.

In yet another variant, the sock is separable from the compression strapsystem.

In yet another variant, the compression strap system is integrated withthe sock.

In yet another variant, the upper retention structure is configured totighten around an anatomy of the user when either: (i) the adjustabletensioning mechanism is tightened and/or (ii) the user's foot goes intoplantar flexion.

In yet another variant, the upper ankle retention structure and thelower ankle retention structure is configured to tighten around theanatomy of the user when the adjustable tensioning mechanism istightened.

In yet another variant, the foot retention structure is configured toplace the foot of the user into a neutral to slight dorsiflexion whenthe adjustable tensioning mechanism is tightened.

In yet another variant, the sock includes low stretch in a horizontaldirection at least in a region adjacent to the ankle of the user and ina region above the calf muscle of the user as compared with at least oneother region of the sock.

In yet another variant, the support strap or the support cable comprisesa substantially inelastic material.

In yet another variant, the sock includes one or more layers of materialand the support strap or the support cable is threaded into and out ofat least one of the one or more layers of material.

In yet another variant, one or more of the upper retention structure,the upper ankle retention structure, the lower ankle retentionstructure, and the foot retention structure is disposed internal to atleast one of the one or more layers of material.

In yet another variant, the sock includes two or more layers of materialand the support strap or the support cable is threaded between at leasttwo of the two or more layers of material thereby preventing directcontact of the support strap or the support cable with skin of the user.

In yet another variant, one or more of the upper retention structure,the upper ankle retention structure, the lower ankle retentionstructure, and the foot retention structure is disposed internal to atleast one of the two or more layers of material.

In yet another variant, the foot ankle orthoses further includes aplurality of support strap/cable guides that is configured to reducefriction and facilitate movement of the support strap or the supportcable.

In yet another variant, a reinforced structure is disposed on a topportion of the foot of the user, the reinforced structure configured toprevent over tensioning of the support strap or the support cable in aregion of the foot of the user.

In another aspect of the present disclosure, a method of manufacturingan orthoses is disclosed. In one embodiment, the method includes weavinga sock, the sock weaved such that the sock has minimal stretch in ahorizontal direction adjacent to a top portion of the orthoses, theankle region of the orthoses and the foot/toe region of the orthoses aswell as in a vertical direction; attaching a connecting point adjacentto the foot/toe region of the orthoses; attaching a rotary tensioningdial adjacent the top portion of the orthoses; and weaving a supportingcable through the sock between the top portion of the orthoses and theconnecting point disposed adjacent to the foot/toe region of theorthoses.

In yet another aspect of the present disclosure, a method of using anorthoses is disclosed. In one embodiment, the method includes placing asock-based orthoses over the lower leg of a user; and applying tensionto a support strap in order to place the user's foot into a neutral toslight dorsiflexion thereby limiting plantarflexion of the ankle.

In another embodiment, the method includes releasing tension to asupport strap; and removing a sock-based orthoses from the lower leg ofa user.

In yet another embodiment, the method includes placing a sock onto a legof a user; pulling a top portion of the sock over a calf muscle on theleg of the user; and adjusting tension of a compression strap system ofthe sock, the adjusting of the tension of the compression strap systemincludes simultaneously: adjusting of tension between a first structurethat is circumferentially spaced from a second structure, the firststructure and the second structure being disposed on an upper retentionstructure; and adjusting tension between the upper retention structureand a foot retention structure.

In one variant, the pulling of the top portion of the sock over the calfmuscle on the leg of the user includes pulling the upper retentionstructure over the calf muscle on the leg of the user.

In another variant, the adjusting of the tension of the compressionstrap system includes rotating a rotary tensioning mechanism in order toadjust tension of a support strap or a support cable that is operativelycoupled with the upper retention structure, an ankle retentionstructure, and the foot retention structure.

Other features and advantages of the present disclosure will immediatelybe recognized by persons of ordinary skill in the art with reference tothe attached drawings and detailed description of exemplaryimplementations as given below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of two exemplary orthoses devices, inaccordance with the principles of the present disclosure.

FIG. 1A is a perspective view of another implementation similar to thosevariants shown in FIG. 1, in accordance with the principles of thepresent disclosure.

FIG. 2 is a front perspective view of another exemplary orthoses devicethat has been integrated into a sock, in accordance with the principlesof the present disclosure.

FIG. 3A is a front perspective view of yet another exemplary orthoses,in accordance with the principles of the present disclosure.

FIG. 3B is a front perspective view of the orthoses depicted in FIG. 3Athat is being utilized in a first configuration, in accordance with theprinciples of the present disclosure.

FIG. 3C is a front perspective view of the orthoses depicted in FIG. 3Athat is being utilized in a second configuration, in accordance with theprinciples of the present disclosure.

FIG. 4A is a front perspective view of yet another exemplary orthosesdevice that been integrated into a sock, in accordance with theprinciples of the present disclosure.

FIG. 4B is a front perspective view of the toe region of the exemplaryorthoses device depicted in FIG. 4A, in accordance with the principlesof the present disclosure.

FIG. 4C is a front perspective view of the top region of the exemplaryorthoses device depicted in FIG. 4A, in accordance with the principlesof the present disclosure.

FIG. 4D depicts the adjustment of the ankle strap of the exemplaryorthoses device depicted in FIG. 4A.

FIG. 4E depicts the adjustment of the support structure and theattachment point of the exemplary orthoses device depicted in FIG. 4A.

FIG. 4F depicts the adjustment of the adjustable strap of the exemplaryorthoses device depicted in FIG. 4A.

FIG. 5A is a front perspective view of yet another exemplary orthosesdevice that been integrated into a sock, in accordance with theprinciples of the present disclosure.

FIG. 5B is a front perspective view of the toe region of the exemplaryorthoses device depicted in FIG. 5A, in accordance with the principlesof the present disclosure.

FIG. 5C is a front perspective view of the top region of the exemplaryorthoses device depicted in FIG. 5A, in accordance with the principlesof the present disclosure.

FIG. 6A is a front perspective view of yet another exemplary orthosesdevice that been integrated into a sock, in accordance with theprinciples of the present disclosure.

FIG. 6B is a front perspective view of the toe region of the exemplaryorthoses device depicted in FIG. 6A, in accordance with the principlesof the present disclosure.

FIG. 6C is a front perspective view of the top region of the exemplaryorthoses device depicted in FIG. 6A, in accordance with the principlesof the present disclosure.

FIG. 7A is a perspective view of exemplary strapping that has beenintegrated into a rigid or semi-rigid AFO, in accordance with theprinciples of the present disclosure.

FIG. 7B is a front view of the exemplary strapping of FIG. 7A that hasbeen integrated into a rigid or semi-rigid AFO, in accordance with theprinciples of the present disclosure.

FIG. 7C is a side view of the exemplary strapping of FIG. 7A that hasbeen integrated into a rigid or semi-rigid AFO, in accordance with theprinciples of the present disclosure.

FIG. 8A is a side view of a first exemplary suspension strap and adynamic loading strap that can be independently controlled usingseparate rotary tensioning systems, in accordance with the principles ofthe present disclosure.

FIG. 8B is a side view of a second exemplary suspension strap and adynamic loading strap that can be controlled using a common rotarytensioning system, in accordance with the principles of the presentdisclosure.

FIG. 8C is a back view of a third exemplary suspension strap and adynamic loading strap that can be independently controlled usingseparate rotary tensioning systems, in accordance with the principles ofthe present disclosure.

FIG. 8D is a perspective view of an exemplary double strapping systemthat has been integrated into a dynamic unloader, in accordance with theprinciples of the present disclosure.

FIG. 9A is a front perspective view of yet another exemplary orthosesdevice that been integrated into a sock, in accordance with theprinciples of the present disclosure.

FIG. 9B is a side perspective view of the orthoses device shown in FIG.9A, in accordance with the principles of the present disclosure.

FIG. 9C is a back perspective view of the orthoses device shown in FIGS.9A and 9B, in accordance with the principles of the present disclosure.

FIG. 10A is a front perspective view of yet another exemplary orthosesdevice with a Y Unloading strap shown on the lateral side of the device,in accordance with the principles of the present disclosure.

FIG. 10B is a front perspective view of the orthoses device of FIG. 10Ashown on the front side of the device, in accordance with the principlesof the present disclosure.

FIG. 10C is a front perspective view of the orthoses device of FIG. 10Ashown on the medial side of the device, in accordance with theprinciples of the present disclosure.

FIG. 10D is a side perspective view of yet another exemplary orthosesdevice with a Y Unloading strap from FIG. 10A using a BOA tensioningmechanism, in accordance with the principles of the present disclosure.

FIG. 10E is a front perspective view of the orthoses device of FIG. 10Don the front side of the device, in accordance with the principles ofthe present disclosure.

FIG. 10F is a flat view perspective of a sleeve used in the Y Unloadingstrap orthoses, in accordance with the principles of the presentdisclosure.

FIG. 10G is a flat view perspective of another sleeve configuration usedin the Y Unloading strap orthoses (showing the gastric and the lowerthigh underneath the panel), in accordance with the principles of thepresent disclosure.

FIG. 10H is a flat view perspective of the configuration of FIG. 10Gshown from the opposite side, in accordance with the principles of thepresent disclosure.

FIG. 10I is a front perspective view of the configuration shown in FIG.10G and/or FIG. 10H in which the sleeve has been separated, inaccordance with the principles of the present disclosure.

All Figures disclosed herein are © Copyright 2017-2018 AST Design, LLC.All rights reserved.

DETAILED DESCRIPTION

Implementations of the present technology will now be described indetail with reference to the drawings, which are provided asillustrative examples so as to enable those skilled in the art topractice the technology. Notably, the figures and examples below are notmeant to limit the scope of the present disclosure to any singleimplementation or implementations, but other implementations arepossible by way of interchange of, substitution of, or combination withsome or all of the described or illustrated elements. Whereverconvenient, the same reference numbers will be used throughout thedrawings to refer to same or like parts.

Moreover, while embodiments described herein are primarily discussed inthe context of foot and ankle orthoses for the treatment of drop foot,it will be recognized by those of ordinary skill that the presentdisclosure is not so limited. In fact, the principles of the presentdisclosure described herein may be readily applied to other parts of theanatomy of a human, and for treatment of conditions other than dropfoot. For example, many common injuries, such as a partial or completetear of a tendon (e.g., a biceps tendon, a triceps tendon, an Achillestendon, and the like), may require an individual to rest the injuredtendon, whether surgical or non-surgical treatment is required.Accordingly, the principles described herein may be readily adapted foruse with other portions of the anatomy. For example, the drop foot sockdevices described herein may be readily adapted for use on the arm,elbow, shoulder, knee (see, for example, FIG. 8D), etc. where movement,whether in extension or flexion, may need to be constrained in order tofacilitate recovery from, for example, an injury or other medicalcondition.

Referring now to FIG. 1, two foot-ankle orthoses 100, 150 are shown anddescribed in detail. Foot-ankle orthoses 100 may include an adjustablestrap 102 (e.g., Velcro) that is disposed at, for example, the top ofthe calf muscle. The disposition at the top of the calf muscle may beadvantageous in some implementations as securing the strap 102 mayprevent the top of the sock from being pulled down over the calf musclewhen the support strap 106 is tightened. In some implementations, theadjustable strap 102 may be placed above the knee and/or at any otherlocation on the anatomy of a subject (e.g., a human or animal) where theprevention of the adjustable strap 102 from being “pulled down” whenunder tension would be readily appreciated by one of ordinary skillgiven the contents of the present disclosure. For example, in someimplementations it may be advantageous to include a first adjustablestrap at the top of the calf muscle and a second adjustable strap justabove the knee. In such a configuration, it may be advantageous to havethe first and second adjustable straps joined together such as is commonwith many extant knee brace configurations.

In some implementations, the adjustable strap 102 may include a rotarytensioning dial 104 (e.g., a so-called BOA® tensioning system). As abrief aside, the rotary tensioning system may include a micro-adjustabledial, a strong lightweight lace or cable, and a low friction lace guide.Accordingly, by rotating the micro-adjustable dial, the rotarytensioning dial may apply tension to the support strap 106 therebybringing the foot into, for example, a neutral to slight dorsiflexionthereby limiting plantarflexion of the ankle which may be advantageousin addressing, for example, a drop foot condition. By tightening therotary tensioning dial 104, the support strap 106 that runs down thetibia may be tightened. Conversely, when loosening the rotatorytensioning dial 104 (e.g., by pulling the dial away from the base), thesupport strap 106 that runs down the tibia may be loosened. Moreover, insome implementations, the rotary tensioning dial 104 may be used toapply tension to support strap 106 as well as adjustable strap 102simultaneously in a similar manner as is described with respect to FIG.8B described infra. In other words, by tightening (or loosening) rotarytensioning dial 104 tension (or lack of tension) may be simultaneouslyapplied to both support strap 106 as well as adjustable strap 102.

The support strap 106 may be secured at the ankle using an ankle strap108. While the support strap 106 is depicted as running underneath theankle strap 108, it would be readily appreciated by one of ordinaryskill given the contents of the present disclosure that alternativeconfigurations are readily recognized. For example, ankle strap 108 mayinclude, for example, a low friction interface that may run through themiddle of ankle strap 108. Alternatively, a low friction interface maybe placed on the top surface of the ankle strap 108. As used herein, theterm “low friction interface” shall mean an interface in which thetensioning (or loosening) of, for example, support strap 106 is notsignificantly impeded as a result of friction. Support strap 106 maycontinue over the dorsum of the foot where it is coupled to a supportingstructure 110.

Supporting structure 110 (that may be implemented into a sock in someimplementations) may allow for circumferential stretching as a means bywhich orthoses 100 remains comfortable to wear by a user. Supportingstructure 110 may possess a more limited ability to stretch in thelongitudinal direction (e.g., along the dorsum of the foot) in order tomaintain, for example, an appropriate amount of tension when tension isapplied (e.g., by pulling the ankle into dorsiflexion), thereby reducingthe effects associated with the drop foot condition.

Foot ankle orthoses 150 may possess many of the same features describedwith respect to foot ankle orthoses 100. For example, orthoses 150 mayinclude an adjustable strap 152, a rotary tensioning dial 154, a supportstrap 156, an ankle strap 158 as well as a supporting structure 160.However, the support strap 156 associated with orthoses 150 isconfigured to rotate around the calf, run over the dorsum of the foot,and anchor to the medial side of the foot. This type of a strappingconfiguration may both: (1) prevent plantar flexion, similar to thatshown with respect to orthoses 100; and (2) reduce pronation, a commoncondition associated with the drop foot condition. Additionally,orthoses 150 may provide rotational control of the ankle and normalizethe gait.

While the support strap 156 is illustrated as providing a singlerotation about a user's tibia, it would be readily appreciated by one ofordinary skill given the contents of the present disclosure that two ormore rotations about a user's tibia may be desirable in someimplementations. Moreover, while support strap 156 is illustrated asbeing anchored to the medial side of the foot, in some implementationsit may be desirable to be anchored to the lateral side of the foot,thereby reducing supination and normalizing the gait of the wearer oforthoses 150. Both of orthoses 100, 150 may be worn with or without asock and both may also be worn with or without a shoe in someimplementations. In the illustrated embodiment, the rotary tensioningdial 154 is shown as being disposed on the lateral side of the leg;however, in some implementations it may be desirable to position therotary tensioning dial at the center of the leg (top portion of theshin), at the center of the leg above the calf, or it may be desirableto position the rotary tensioning dial on the medial side of the leg(such as when support strap 156 is anchored on the lateral side of thefoot, etc.). These and other variations would be readily apparent to oneof ordinary skill given the contents of the present disclosure.

FIG. 1A illustrates another variant of orthoses 100, 150, which uses aVelcro system to anchor the suspension strap at the top of the calf aswell as for the adjustable rotation/dorsi flexion support strap. In thisconfiguration, both straps may be stretchable or may be inelastic. Inimplementations in which one or more of these straps is stretchable,these straps may provide for dynamic (e.g., changing) support throughoutthe entire gait cycle. The sock properties may remain the same (orsimilar) as those described with respect to orthoses 100, 150. Eachstrap may be permanently attached to sock via, for example, a sewed endat one end and attached through a “D ring” at another end. In someimplementations, the D rings may be soft and pliable and could also besewn into the sock as well in some implementations.

Referring now to FIG. 2, another foot ankle orthoses 200 is shown anddescribed in detail. Orthoses 200 has been integrated into a sock. Insome implementations, the sock has minimal if any vertical stretch goingfrom the toes up the calf so as to maintain, for example, an appropriateamount of tension (e.g., by pulling the ankle into dorsiflexion) therebyreducing the effects associated with the drop foot condition, whileallowing for an increased amount of stretch in the horizontal directionso as to, inter alia, make it easy to put on and/or take off theorthoses 200.

Similar to the embodiments illustrated in FIG. 1, the orthoses 200includes an adjustable strap 202 positioned, for example, above the calfmuscle. Adjustable strap 202 further includes a support structure 204having support ring 206. In some implementations, support structure 204may be sewn or otherwise fixedly attached to adjustable strap 202. Inalternative implementations, support structure 204 may be removablyattached to, for example, adjustable strap 202 such as via, for example,Velcro, or a clip (e.g., that is positioned over the top of adjustablestrap 202, or mates with a respective hook or other means on (orunderneath) the adjustable strap 202, etc.).

Orthoses 200 may further include an ankle strap 210 and a foot strap212. Ankle strap 210 and foot strap 212 assists in keeping the supportstrap 208 flush against the leg when under tension. While the supportstrap 208 is depicted as running underneath the ankle strap 210 and footstrap 212, it would be readily appreciated by one of ordinary skillgiven the contents of the present disclosure that alternativeconfigurations are readily appreciated. For example, one or both ofankle strap 210 and foot strap 212 may include, for example, a lowfriction interface that may run through the middle of ankle strap 210and/or foot strap 212 or may be placed on the top surface of the anklestrap 210 and/or foot strap 212. One or both of ankle strap 210 and footstrap 212 may be fixedly secured to the sock, or alternatively may beremovably secured (e.g., strap 210 and/or strap 212 may be separatelyattachable) in order to allow, for example, further customization of thepositioning of these straps 210, 212 in relation to a given user'sanatomy.

Support strap 208 may be fixedly secured adjacent to the toe region ofthe sock. The opposite end 216 of the support strap 208 may be routedthrough support ring 206 and secured back on itself in order to bringthe foot into, for example, a neutral to slight dorsiflexion therebylimiting plantarflexion of the ankle which may be advantageous inaddressing, for example, the aforementioned drop foot condition. In someimplementations, an identifiable marker 218 may be placed on the supportstrap 208 so as to enable a user of the orthoses to apply an appropriatelevel of tension for their desired level of, for example, their dropfoot condition. In some implementations, the identifiable marker 218 maybe obviated in view of another mechanism (e.g., Velcro, clasp, or othermechanism) in order to ensure a repeatable amount of an appropriatelevel of tension for a given user. In some implementations, the level oftension may be determined by a doctor or other skilled technician asopposed to being determined by the user themselves.

Referring now to FIGS. 3A-3D, various different configurations ofstrapping that may be utilized in order to provide a combination ofdorsiflexion/inversion/eversion/rotation support is shown and describedin detail. While the orthoses 300 shown in FIGS. 3A-3D is shown as beingused as a separate device, it would be readily appreciated by one ofordinary skill given the contents of the present disclosure that theorthoses of FIGS. 3A-3D may be integrated into a sock (such as a socksimilar to that illustrated in FIG. 2) in some implementations.

FIG. 3A illustrates an orthoses 300 with an adjustable strap 302 (e.g.,a Velcro strap) that is disposed at, for example, the top of the calfmuscle. Similar to other implementations described elsewhere herein, thedisposition of the adjustable strap at the top of the calf muscle may beadvantageous in some implementations as securing the strap 302 mayprevent the top of the orthoses from being pulled down over the calfmuscle when the support strap 306, 308 is tightened. Support strap 306may include a rotary tensioning dial 304 (e.g., a BOA® tensioningsystem) that is configured to provide tension to the support straps 306,308. Orthoses 300 may further include a supporting structure 310 (andsock in some implementations) that may allow for circumferentialstretching as a means by which orthoses 300 remains comfortable to wearby a user. In the illustrated embodiment, supporting structure providesfor an anchor point for straps 306, 308 around the dorsum of the foot inthe metatarsal region. Supporting structure 310 may possess a morelimited ability to stretch in the longitudinal direction (e.g., alongthe dorsum of the foot) in order to maintain, for example, anappropriate amount of tension (e.g., by pulling the ankle intodorsiflexion) when support straps 306, 308 are placed under tension,thereby reducing the effects associated with the drop foot condition.

The adjustable strap 302 may also possess two anchor points, one forattachment of strap 306 (via rotary tensioning system 304) and one forattachment of strap 308. In some implementations (such as thatillustrated in FIG. 3A), strap 306 is configured to be anchored mediallyon adjustable strap 302, while strap 308 is configured to be anchoredlaterally on adjustable strap 302. In some implementations (not shown),the positioning of these anchor points may be reversed such that strap308 is anchored medially on adjustable strap 302, while strap 306 may beanchored laterally on adjustable strap 302. The two adjustable straps306, 308 may be made from an elastic material in some implementationsand are configured to connect to each respective anchor point on theadjustable strap 302 such that they spiral around the leg in oppositedirections from one another. In other words, as illustrated strap 306may be wound around the leg of a user in a clockwise direction, whilestrap 308 may be wound around the leg of a user in a counter-clockwisedirection. The orthoses 300 illustrated in FIG. 3A is configured toprovide a dynamic dorsi-flexion support with inversion/eversion supportas well as provide for rotational stability for the ankle. In someimplementations, each of straps 306, 308 may be discrete components(i.e., separate components) that may either be fixedly secured or,alternatively, may be removably secured to supporting structure 310. Inalternative implementations, each of straps 306, 308 and supportingstructure 310 may be manufactured as a unitary component.

Referring now to FIG. 3B, an alternative configuration 320 to that shownin FIG. 3A is shown. In this particular configuration, strap 306 may bemedially attached to the adjustable strap 302 and laterally attached tothe supporting structure 310. In such a configuration, orthoses 320 maycreate a dynamic dorsi-flexion support with inversion support as well asproviding for rotational stability for the ankle.

Referring now to FIG. 3C, yet another alternative configuration 340 tothat shown in FIGS. 3A and 3B is shown and described in detail. In thisparticular configuration, strap 306 may be laterally attached to theadjustable strap 302 and medially attached to the supporting structure310. In such a configuration, orthoses 340 may create a dynamicdorsi-flexion support with eversion support as well as providing forrotational stability for the ankle.

In some implementations, the support strap may be secured, for example,medially (or laterally) at the top of the calf of a user at a top anchorpoint. The support strap may then spiral across the knee joint andultimately be positioned on the same side as the top anchor point on thefoot. Such a configuration may possess advantages in providing dynamicknee support for, for example, Osteoarthritis treatment.

Referring now to FIGS. 4A-4F, yet another ankle foot orthoses 400 isshown and described in detail. In particular, orthoses 400 ismanufactured as a sock. In some implementations, the sock ismanufactured so as to have a high stretch in the horizontal direction(e.g., across the foot, etc.), and a lesser amount of stretch in thevertical direction (e.g., along the shin). As discussed elsewhereherein, this high stretch in the horizontal direction enables theorthoses 400 to be taken on (and off easily), while the low stretch inthe vertical direction assists in providing the requisite support toenable sufficient dorsi-flexion support for the foot. An adjustablestrap 402 is provided for positioning and retention of the orthoses at,for example, the top of the calf of a user. The adjustable strap 402 maybe adjusted using, for example, Velcro in some implementations. Othersecuring means may be provided in addition to, or alternatively from theaforementioned Velcro, in other implementations including, withoutlimitation, fasteners such as buttons, clasps, snaps/press studs,zippers, safety pins, hooks and eye fasteners, frog fasteners, togglefasteners, metal fasteners, grommets/eyelets, glass studs, and the like.Adjustable strap 402 further includes a support structure 404 having anattachment point 406. In some implementations, support structure 404 maybe sewn or otherwise fixedly attached to adjustable strap 402. Inalternative implementations, support structure 404 may be removablyattached to adjustable strap 402 such as via, for example, Velcro, aclip (e.g., that is positioned over the top of adjustable strap 402, ormates with a respective hook or other means on (or underneath) theadjustable strap 402, etc.).

Orthoses 400 may further include an ankle strap 410 and a foot support414 which provides for additional adjustable anchor points in the ankleregion and around the toe area of the foot in some implementations.Ankle strap 410 (and to an extent foot support 414) assists in keepingthe support strap 408 flush against the leg/foot when under tension.This ability to keep the support strap 408 flush against the leg/footenables the orthoses 400 to be utilized with, for example, shoes. Thesupport strap 408 provides for an adjustable tensioning mechanism thatis configured to connect to a connecting point 412, travel over thedorsum of the foot through (or underneath) ankle strap 410, and up thetibia for attachment to attachment point 406 located on the supportstructure 404. In some implementations, support strap may include one ormore of a tensioning cable, an inelastic strap, or an elastic strap.Accordingly, by appropriately tensioning support strap 408, one mayprovide for sufficient dorsi-flexion support. While the support strap408 is depicted as running underneath the ankle strap 410, it would bereadily appreciated by one of ordinary skill given the contents of thepresent disclosure that alternative configurations are readilyappreciated. For example, the ankle strap 410 may include, for example,a low friction interface that may run through the middle of ankle strap410 or may be placed on the top surface of the ankle strap 410. Anklestrap 410 may be fixedly secured to the sock, or alternatively may beremovably secured (e.g., strap 410 may be separately attachable) inorder to allow for, for example, further customization of thepositioning of this strap 410 in relation to a given user's anatomy.

Support strap 408 may be fixedly secured adjacent to the foot support414 of the sock. The opposite end of the support strap 408 may besecured at or near support ring 406 in order to bring the foot into, forexample, a neutral to slight dorsiflexion thereby limitingplantarflexion of the ankle which may be advantageous in addressing, forexample, the aforementioned drop foot condition. For example, in someimplementations (such as that shown in FIG. 4A), foot support 414 may bepositioned over the user's toes and may include a closed sleeve (orpocket) at connecting point 412. In some implementations, foot support414 may be placed on the medial side (and/or lateral side) of the foot(e.g., adjacent to the metatarsal region). Such a configuration may beuseful in providing additional eversion (and/or inversion) support,particularly when support strap 408 (or support straps) are wrappedaround the lower portion of the user's leg (such as in the fashiondescribed with respect to the implementations of FIGS. 3A-3C). Moreover,in some implementations, the support ring 406 may be obviated in view ofa rotary tensioning mechanism such as that described with respect to,for example, FIGS. 3A-3C.

FIG. 4B illustrates a close up view of the foot region of orthoses 400.In particular, support cables 408 are shown adjacent to connecting point412. In particular, connecting point 412 includes a sleeve through whichsupport cables 408 may be routed therethrough.

FIG. 4C illustrates the top portion of orthoses 400. In particular, insome implementations, support structure 404 may be removably attached tothe upper portion of orthoses via Velcro. In some implementations, thelength dimension of support structure 404 may, in combination with thelength of support straps/cables 408 be configured to provide apredetermined amount of tension when placed at top portion of orthosesso as to ensure, inter alia, an appropriate amount of dorsi flexion. Insome implementations, other attachment methods may be utilized includingone or more of a buckle, a magnet, and/or other fastening methods. Inyet other implementations, support structure may be non-adjustable,while still promoting sufficient dorsi flexion support.

FIG. 4D illustrates the adjustment of ankle strap 410 with Velcro. Inparticular, ankle strap 410 ensures that the support strap 408 (e.g.,dorsi flexion assist strap) is maintained close to the leg at all timeswhen support strap 408 is placed under tension. FIG. 4E illustrates theadjustment of support structure 404 and attachment point 406 whichenables, inter alia, that the support strap 408 (e.g., dorsi flexionassist strap) can be adjusted in terms of tension. FIG. 4F illustratesadjustment of the adjustable strap 402 in accordance with someimplementations of the present disclosure. The use of adjustable strap402 ensures that the sock doesn't slip down the leg when the supportstrap 408 is tightened.

Referring now to FIGS. 5A-5C, yet another foot ankle orthoses 500 isshown and described in detail. In particular, orthoses 500 has beenintegrated into a sock. In some implementations, orthoses 500 includes aretention structure 502, a support structure for a rotatory tensioningmechanism 504, support strap(s) (or cable(s)) 508, attachment point 512,and supporting structure 514 disposed adjacent to the toes of a user oforthoses 500. The underlying drop foot sock may, in someimplementations, include low stretch in the horizontal direction in theregion of the ankle and at the top of the calf (i.e., in the region ofretention structure 502). The underlying drop foot sock may include ahigher amount of stretch in the horizontal direction in one or moreother regions so as to enable orthoses 500 to be put on, and taken off,easily, while also providing for improved comfort. Orthoses 500 may alsoinclude low stretch in the vertical direction to ensure proper stabilityof the dorsi flexion support strap/cable 508.

Moreover, in the illustrated embodiment, support strap 508 is shown asan inelastic cable that is threaded within the underlying sock so as toenable, inter alia, the obviation of an ankle support strap. In someimplementations, the inelastic cables are threaded in and out of thesock twice along the tibia region, and threaded in again just above theankle and out again adjacent the navicular bone of the foot. In someimplementations, the support strap 508 (e.g., inelastic cable) may bethreaded into the underside of sock (i.e., support strap 508 may bethreaded so that portions thereof are disposed adjacent to, for example,the skin of a wearer of orthoses 500), while in other implementationsthe support strap 508 may be threaded inside of the sock such that thematerial of the sock is disposed between the skin of a wearer and thesupport strap 508 so as to mitigate irritation to the user's skin bysupport strap 508 in some implementations. In some implementations, itmay be desirable to thread support strap 508 entirely within the sock.Regardless of the particular implementation chosen, by virtue of thesupport strap 508 being threaded into (and out of) the underlying sockmaterial (or within the underlying sock material), the support strap 508may be placed proximate to the user's foot/leg when the support strap508 is placed under tension via, for example, rotary tensioningmechanism 504. In other implementations (not shown), the support strapmay be disposed entirely (or almost entirely) within the sock (orunderneath the sock) for the purpose of making orthoses 500aesthetically pleasing. Preferably, orthoses 500 may be utilized with(or without) a standard set of shoes, boots, etc.

Referring now to FIG. 5B, a close up view of the toe region of orthoses500 is shown and described in detail. In particular, connecting point512 is shown which may comprise a plastic material having a curvedrouting cavity for receiving support strap 508. Additionally, in someimplementations, a supporting structure 514 may be disposed adjacent toconnecting point 512. The purpose of supporting structure 514 is to,inter alia, prevent the vertical stretch of orthoses 500 in thisparticular region when support strap 508 is placed under tension. Insome implementations, both supporting structure 514 and connecting point512 are attached to the underlying sock by being threaded thereon.

Referring now to FIG. 5C, a close up view of the top portion of orthoses500 is shown and described in detail. Specifically, unlike priorembodiments, the top portion of orthoses does not include an adjustablestrap in the illustrated embodiment. Rather, the retention structure 502may be formed from the underlying sock material that enables orthoses500 to remain secured above a user's calf muscle without having to applyan additional tightening step (such as that shown with reference to FIG.4F). In other words, retention structure 502 ensures that a sufficientamount of horizontal tension of the underlying sock material is placedaround the top of a user's calf muscle so as to enable the sock to stayin place when support strap 508 is tightened. Additionally, rotarytensioning dial 504 may be attached to a supporting fabric 506 which issewn in the top region of orthoses 500. Accordingly, through use ofsupporting fabric 506, retention structure 502 and supporting structure514 (FIG. 5B), additional support may be provided to orthoses 500 so asto prevent the top of orthoses 500 from being pulled down over, forexample, a user's calf muscle when support strap 508 is placed undertension.

Referring now to FIGS. 6A-6C, a similar orthoses 600 is shown as thatshown and described with respect to FIGS. 5A-5C. In particular, orthoses600 has been integrated into a sock, and further orthoses 600 includes atensioning strap 602, support strap(s) or cable(s) 608, attachment point612, and a supporting structure 614 disposed adjacent to the toes of auser of orthoses 600. The underlying drop foot sock may, in someimplementations, include low stretch in the horizontal direction in theregion of the ankle and at the top of the calf. The underlying drop footsock may further include a higher amount of stretch in the horizontaldirection in other portions of orthoses 600 so as to enable orthoses 600to be put on, and taken off, relatively easily, while also providing forimproved comfort. Orthoses 600 may also include low stretch in thevertical direction to ensure proper stability of the dorsi flexionsupport strap/cable 608. However, unlike like orthoses 500 shown withrespect to FIGS. 5A-5C, orthoses 600 includes, for example, a Velcrostructure 604 that is utilized to apply tension to support straps 608 aswill be described subsequently herein with respect to FIG. 6C.

FIG. 6B illustrates the toe region of orthoses 600. In particular,connecting point 612 is shown which may comprise a fabric that includesa channel through which support strap 608 is received. By virtue ofbeing made from fabric, connecting point 612 may provide for addedcomfort when orthoses 600 is worn with, for example, shoes. In someimplementations, connecting point 612 may instead include a plasticmaterial having a curved routing cavity for receiving support strap 608(similar to that described with reference to FIG. 5B). Additionally, insome implementations, a supporting structure 614 may be disposedadjacent to connecting point 612. The purpose of supporting structure614 is to, inter alia, prevent the vertical stretch of orthoses 600 inthis particular region when support strap 608 is placed under tension.In some implementations, both supporting structure 614 and connectingpoint 612 are attached to the underlying sock by being threaded thereon.Additionally, regions 609 where support strap 608 may be woven within(or underneath) the underlying sock material is also illustrated.

Referring now to FIG. 6C, a close up view of the top portion of orthoses600 is shown and described in detail. Specifically, and similar to thatdescribed with reference to FIG. 5C, the top portion of orthoses 600does not include an adjustable strap in the illustrated embodiment.Rather, the tensioning strap 602 may include a reinforced structure thatenables orthoses 600 to remain secured above a user's calf musclewithout having to apply an additional tightening step (such as thatshown with reference to FIG. 4F). Additionally, the Velcro structure 604may be more readily seen. In particular, Velcro structure 604 may besecured to a Velcro portion of material 606 at a top region of orthoses600. Moreover, Velcro structure 604 may further include connecting point607 that may include a plastic material having a curved routing cavityfor receiving support strap 608 (similar to that described withreference to FIG. 5B). The Velcro portion of material 606 may include anidentifying mark (not shown) that may assist in applying a consistentamount of tension to support straps 608 in some implementations. In someimplementations, the level of tension (and position of identifying mark)may be determined by a doctor or other skilled technician as opposed tobeing determined by the user themselves. Additionally, and similar tothat described with reference to FIGS. 3A-3C, orthoses 500, 600 mayinclude anchor points on the medial and/or lateral side of the foot andanchor points on the medial and/or lateral side of the leg in someimplementations. Such embodiments, and depending upon the configurationchosen, may be utilized in order to provide a combination ofdorsiflexion support, inversion support, eversion support, and/orrotation support for the user of orthoses 500, 600.

Referring now to FIGS. 7A-7C, yet another foot ankle orthoses 700 isshown and described in detail. For example, FIG. 7A illustrates a rigidor semi-rigid AFO that includes a dynamic semi-flexible foot supportsection 714, an L-shaped frame 710 that is configured to be disposedaround the foot and ankle and run up along a user's calf muscle, and asupporting structure 708 that is configured to fit adjacent to a user'sknee. In some implementations, supporting structure 708 may bemanufactured from a heat-moldable plastic, metal, leather, a carboncomposite material, or various combinations of the foregoing. Supportstrap 706 may be anchored on the medial side of the foot in region 712,and further be anchored to a rotary tensioning system 704. Orthoses 700may further include an adjustable strap 702 which may be secured toanchoring fabric 716 that is disposed on the supporting structure 708.

Referring now to FIG. 7B, orthoses 700 is shown being put on (or takenoff) of the leg of a user. As can now more readily be seen, supportstrap 706 may be wrapped in a clock-wise direction around the lower legof the user where both adjustable strap 706 and support strap 706 areattached to a rotary tensioning system 704. Accordingly, when rotarytensioning system 704 is secured to, for example, anchoring fabric (716,FIG. 7A), both adjustable strap 702 and support strap 706 may besimultaneously placed under tension through adjustments made through therotary tensioning system 704. FIG. 7C illustrates orthoses 700 after anappropriate amount of tension has been applied via rotary tensioningsystem 704. The orthoses 700 as shown in FIGS. 7A-7C may include carbonfiber. Via inclusion of the support strap 706 (which may be eitherelastic or inelastic), an additional dorsiflexion support is provided,as well as inversion/eversion support dependent upon the direction ofrotation for the support strap 706 and proper tibia alignment throughoutthe gait, similar to what a spiral carbon fiber orthoses would provide.Adding such a strap 706 onto this brace may add increased complexity ofdonning, however when configured with a rotary tensioning system 704(e.g., a BOA dial) that allows for two (or more) straps to be adjustedat the same time, one can provide a greater level of function to theorthoses while simultaneously adding to the ease of donning and doffing.

Referring now to FIG. 8A, an alternative strapping configuration 800 isshown that may be utilized with one or more of the aforementionedorthoses described herein. In particular adjustable strap 802 may beplaced under tension using rotary tensioning system 804, while supportstrap 806 may be placed under tension using a separate rotary tensioningsystem 808. Moreover, adjustable strap 802 and rotary tensioning system808 may be removably (or fixedly) secured to supporting structure 810.In some implementations, these two straps may be mounted to the brace inthe same (or similar) location thereby providing for the same ease ofdonning as described in, for example, FIG. 7B, but with a greater levelof detailed adjustment per each strap.

FIG. 8B illustrates yet another alternative strapping configuration 820that may be utilized with one or more of the aforementioned orthosesdescribed herein. In particular adjustable strap 822 may be placed undertension using rotary tensioning system 824, while support strap 826 maybe simultaneously placed under tension using the same rotary tensioningsystem 824. Moreover, adjustable strap 822 and rotary tensioning system824 may be removably (or fixedly) secured to supporting structure 830.

FIG. 8C illustrates yet another alternative strapping configuration 840that may be utilized with one or more of the aforementioned orthosesdescribed herein. In particular adjustable strap 842 may be placed undertension using rotary tensioning system 844, while support strap 846 maybe simultaneously placed under tension using another rotary tensioningsystem (not shown). For example, rotary tensioning system 844 may beplaced on the front of the leg (e.g., near the top of the shin), whilethe other rotary tensioning system may be placed on the back side of theleg (e.g., near the top of the calf muscle).

FIG. 8D illustrates yet another alternative strapping configuration 870that may be utilized with, for example, a knee brace 860 (such as, forexample, the Unloader One® manufactured by Ossur). In the illustratedembodiment, the lower portion 862 of knee brace 860 may have a rotarytensioning system 864 disposed on the lateral side of the knee brace.The rotary tensioning system 864 may simultaneously apply tension aroundthe calf muscle using adjustable strap 866 and support strap 868. Theother end of the support strap 868 may be fixedly (or removably) securedto a top portion of the knee brace 860 on the medial side of the leg.Such a configuration may enable the underlying knee brace to laterallyunload the knee. The top portion of the knee brace (not shown) mayfurther include a thigh strap (not shown).

Moreover, while the rotary tensioning system 864 is illustrated as beingdisposed on the lateral side of the knee brace, it would be appreciatedby one of ordinary skill given the contents of the present disclosurethat the rotary tensioning system 864 may alternatively be placed on themedial side of the lower portion 862 of knee brace 860 with the supportstrap 868 spiraling up the leg with the opposing end secured to thethigh frame at the anterior/medial side. Such a configuration may enablethe underlying knee brace to medially unload the knee. The rotarytensioning system 864 may simultaneously apply tension around the calfmuscle using adjustable strap 866 and support strap 868.

Moreover, other dispositions of the rotary tensioning system 864 arereadily envisaged given the contents of the present disclosure,including on the top of the leg (e.g., near the top of the shin), theback of the leg (e.g., near the top of the calf), or even on otherdispositions on the top portion of knee brace 860. For example, in someimplementations it may be desirable to include, for example, a firstrotary tensioning system 864 disposed on the lateral (or medial) side ofthe lower portion 862 of the knee brace 860 with a first support strap868 spiraling up the leg and being secured on the medial (or lateral)side of the top portion of the knee brace 860. Additionally, a secondrotary tensioning system 864 may be disposed on the lateral (or medial)side of the top portion of the knee brace with a second support strap868 spiraling down the leg (e.g., in an opposite direction to the firstsupport strap 868) and being secured on the medial (or lateral) side ofthe lower portion 862 of the knee brace 1860. In some implementations,tightening of the first rotary tensioning system 864 may simultaneouslytighten the first support strap 868 and adjustable strap 866 around thecalf muscle, while tightening of the second rotary tensioning system 864may simultaneously tighten the second support strap 868 and adjustablestrap 866 around the thigh muscle. These and other variants would bereadily apparent to one of ordinary skill given the contents of thepresent disclosure.

Referring now to FIGS. 9A-9C, yet another foot ankle orthoses 900 isshown and described in detail. In some implementations, orthoses 900 maybe integrated into a sock 902 as illustrated. As illustrated, the sockmay consist of an over the calf sock 902 (i.e., the sock is configuredto reach over a wearer's calf muscle). However, in alternativeimplementations orthoses 900 may be distinct and separate from anunderlying sock and may be utilized (or not utilized) in conjunctionwith a separate and distinct sock. For example, the compression strapsystem (e.g., retention straps 906, 910, 912, 914; support strap(s) (orcable(s)) 908; and rotary tensioning mechanism 904) may be separablefrom the sock 902 for the purposes of, for example, enabling the sock902 to be cleaned independent from the compression strap system.

The foot ankle orthoses 900 may be utilized as an aid device for dropfoot patients; however, such a means for utilization is not the onlycondition for which foot ankle orthoses 900 may be utilized. Forexample, foot ankle orthoses 900 may be used as a sleeve to control, forexample, swelling/edema in a patient. Additionally, or alternatively,foot ankle orthoses may be utilized to serve as a proprioceptivereminder device in some implementations. For example, for a wearer ofthe foot ankle orthoses 900 who is dealing with an injury to the lowerpart of their leg, the foot ankle orthoses 900 may be used as anindicator that, for example, the wearer is over-exerting themselvesduring rehabilitation exercises as but one example. In other words, thepressure applied to the lower part of the leg by the foot ankle orthoses900 may act as a reminder (e.g., such as an increase in pressure causedby swelling as but one example) to a wearer rehabilitating an injury,thereby promoting increased attention to the injury itself.Additionally, foot ankle orthoses 900 may help alleviate fatigue as; forexample, the support strap(s) 908 (or cable(s)) are precisely tightenedto predetermined (e.g., comfortable) specifications. These and otherapplications for the foot ankle orthoses 900 would be readily apparentto one of ordinary skill given the contents of the present disclosure.

The sock 902 (and/or compression strap system) may include features thatallow for improved mating between the sock 902 and the compression strapsystem in implementations in which the sock 902 is separable from thecompression strap system. For example, the sock 902 and/or compressionstrap system may include Velcro or other suitable means to removablycouple the sock 902 with the compression strap system. The sock 902 mayinclude integrated rubber beads to prevent, inter alia, movement of thesock 902, with respect to the user's leg and/or the compression strapsystem, when a wearer of the sock is in motion. These integrated rubberbeads may be integrated within the sock (i.e., for contact against awearer's skin) and/or may be integrated on an external portion of thesock (e.g., for contact with one or more straps of the compression strapsystem). In some implementations, these integrated rubber beads may beintegrated within the compression strap system itself in addition to, oralternatively from, integrated rubber beads on the sock itself (whetherinternal, and/or external, to the sock 902).

In some implementations, orthoses 900 may include an upper retentionstructure 906, a rotatory tensioning mechanism 904 (such as, forexample, the aforementioned BOA® tensioning system), support strap(s)(or cable(s)) 908, an upper ankle retention structure 910, a lower ankleretention structure 912, and a foot retention structure 914 which may bedisposed adjacent to, for example, the ball of the foot (i.e., thepadded portion of the sole of the foot between the toes and the arch).These retention structures 906, 910, 912, 914 may be manufactured from asame (or similar) underlying material, or may alternatively bemanufactured from disparate materials. These materials may include, forexample, fabrics, rubber-like materials, plastics, resins and/orsynthetic materials. Additionally, these retention structures 906, 910,912, 914 may be integrated with the sock 902 in, for example, inelasticknitting zones of the sock 902. These retention structures 906, 910,912, 914 (or portions thereof) may also be integrated external to thesock (as illustrated), integrated internal to the sock 902 (i.e.,between two or more layers of the underlying sock material) and/orintegrated internal to all layer(s) of the sock 902.

The underlying sock 902 may, in some implementations, include lowstretch in the horizontal direction at least in the region of the ankleand at the top of the calf (i.e., in the region of upper retentionstructure 906). The underlying sock may include a higher amount ofstretch in the horizontal direction in one or more other regions so asto enable orthoses 900 to be put on, and taken off, easily, while alsoproviding for improved comfort. Orthoses 900 may also include lowstretch in the vertical direction to ensure proper stability of thedorsi flexion support strap/cable 908.

Moreover, in the illustrated embodiment, support strap 908 is shown asan inelastic cable that is threaded within the underlying sock so as toenable, inter alia, decreased visibility of the support strap 908. Insome implementations, the support strap 908 (e.g., inelastic cable) maybe threaded into the underside of sock (i.e., support strap 908 may bethreaded so that portions thereof are disposed adjacent to, for example,the skin of a wearer of orthoses 900), while in other implementationsthe support strap 908 may be threaded inside of the sock such that thematerial of the sock is disposed between the skin of a wearer and thesupport strap 908 so as to mitigate irritation to the user's skin bysupport strap 908. In some implementations, it may be desirable tothread support strap 908 entirely within the sock. By virtue of thesupport strap 908 being threaded into (and out of) the underlying sockmaterial (or within the underlying sock material), the support strap 908may be placed proximate to the user's foot/leg when the support strap908 is placed under tension via, for example, rotary tensioningmechanism 904. In other implementations (not shown), the support strapmay be disposed entirely (or almost entirely) within the sock (orunderneath the sock) for the purpose of making orthoses 900, inter alia,aesthetically pleasing. In yet other implementations, support strap 908may be positioned external to the sock 902 and may be held in closeproximity to the wearer by virtue of the interface portions of thesupport strap 908 with the retention structures 906, 910, 912, 914.Preferably, orthoses 900 may be utilized with a standard set of shoes,boots, etc., in some implementations.

Retention structures 906, 910, 912, 914 may integrate supportstrap/cable guides in some implementations at the point where thesupport strap/cable 908 interfaces with respective ones of the retentionstructures 906, 910, 912, 914. The purpose of these support strap/cableguides is to reduce friction and facilitate movement of the supportstrap/cable 908 as this support strap/cable is tightened (or loosened)with respect to the retention structures 906, 910, 912, 914. Thesesupport strap/cable guides may include one or more of lace guides thatare manufactured from, for example, fabric, rubber, plastics, metals,resins and/or synthetics. In some implementations, one or more of thesesupport strap/cable guides may include a pulley, hook, hollow rivet,etc. that may be utilized to guide the support strap/cable 908 duringtightening (or loosening) operations.

These retention structures 906, 910, 912, 914 may be positioned atvarious strategic contours associated with the anatomy of the wearer.For example, upper retention structure 906 may be positioned above thecalf of a wearer and below the knee, upper ankle retention structure 910may be positioned below the calf and above the ankle, lower ankleretention structure 912 may be positioned below the ankle at atransition point between a wearers heel and the arch of the foot (i.e.,at a transition point between the hind foot and the midfoot of awearer), and foot retention structure may be positioned between the ballof a user's foot and the arch of the foot. In other words, positioningthese retention structure(s) 906, 910, 912, 914 at areas of contour(e.g., portions of the anatomy that get “skinny”) provides for improvedanchor points for the compression strap system. In some implementations,various one(s) of these retention structures may be removed (e.g., lowerankle retention structure 912 and/or upper ankle retention structure910, etc.). In some implementations, there may be a need for at leastthree of these retention structures (e.g., retention structure 906,retention structure 910 or 912, and retention structure 914) so as toproperly provide sufficient support while maintaining the tensioningelement in close proximity to the leg.

In some implementations, the compression strap system may be integratedonto other wearable support structures other than the foot ankleorthoses 900 explicitly shown. For example, in the context of an arm andelbow orthoses (not shown), retention structures may be placed above thebicep, above and/or below the elbow and at the wrist as but oneexemplary example. As but another exemplary example in the context of aleg and knee orthoses, retention structures may be placed at the top ofthe thigh, above and/or below the knee and below the calf. In sum,various embodiments may be envisioned for use on various portions of thehuman anatomy with retention structures (e.g., anchor points) beingpositioned at various portions of the anatomy which go from eitherlarger diameter to smaller diameter or from smaller diameter to largerdiameter, etc. These and other variations would be readily apparent toone of ordinary skill given the contents of the present disclosure.

While the use of an exemplary rotary tensioning mechanism 904 isillustrated, it would be readily apparent to one of ordinary skill giventhe contents of the present disclosure that this mechanism 904 may beobviated in favor of alternatives (such as the exemplary alternativesdisclosed herein). For example, the rotary tensioning mechanism 904 maybe obviated in favor of the support structure 204 having support ring206 as shown in FIG. 2. As but yet another example, the rotarytensioning mechanism 904 may be obviated in favor of the supportstructure 404 having an attachment point 406 as shown in FIG. 4A. In yetother envisioned variants, the rotary tensioning mechanism may beobviated in favor of “shoe lace”-type configuration in which thecinching of the shoe lace provides both a tightening of each of theretention structures 904, 910, 912, 914 along with a simultaneousmaintaining of the foot in a neutral to slight dorsiflexion thuslimiting plantarflexion of the ankle. This shoe lace-type configurationmay utilize, for example, a shoe lace, rubber, fabric, Velcro, rope,elastic bands, cords, and/or springs, etc. These and other variationswould be readily apparent to one of ordinary skill given the contents ofthe present disclosure.

Referring to FIG. 9A in particular, and in some implementations, it maybe desirable to utilize a reinforced structure 916 at the top portion ofthe foot in between, for example, the opposing ends of the footretention structure 914. In particular, one purpose for this reinforcedstructure 916 may be to prevent the over tensioning of the supportstrap(s) (cable(s)) 908 in the region of the toes where the pressure iscreated in order to lift (support) the toes. In other words, in someimplementations, it may be desirable to make this area of orthoses 900 ano (or low) tension zone around the periphery of the foot for thepurpose of making the orthoses 900 more comfortable to wear. Thisreinforced structure 916 may consist of, for example, plastic, rubber,reinforced fabrics and/or metal. In some implementations, the reinforcedstructure may be custom shaped for a given users anatomy, therebyproviding for additional comfort when wearing the orthoses 900.Additional support strap/cable guides (not shown) may be provided onadditional portions at the top of the foot (and/or along the lower leg)in order to provide additional support and comfort for a user oforthoses 900. Additional padding (and/or support) may be providedunderneath (or around) retention structure(s) 906, 910, 912 and/or 914dependent upon particular user preference for the purpose of providingadditional comfort. The underside of the foot may also include paddedareas (e.g., via the addition of foam, fabric and/or rubber, etc.) foradded comfort. The addition of these padded areas may help prevent theuser from feeling excess tension as the retention structure(s) 906, 910,912 and/or 914 are placed under tension and may also be configured for aparticular user's preferences. It should be noted that at least in someimplementations, when a user's ankle goes into plantar flexion, thestrap(s) (cable(s)) 908 may in response tighten. When the strap(s)(cable(s)) 908 tightens it may have a tendency to want to pull the sockdown the leg. Since the strap(s) (cable(s)) 908 is attached (threaded)through retention strap 906 that is positioned above the calf, it willhave a tendency to want to “pull” on this retention strap 906, which inreturns provides for a greater level of suspension as strap(s)(cable(s)) 908 tighten. Accordingly, this mechanism may be thought of asa dynamic suspension system that may be used on any of the retentionstraps as well as used for different joints for various otherpathologies.

Referring now to FIGS. 10A-10I various unloading style braces that mayinclude a wrap around sleeve, a single upright frame and a Y strapunloading feature is shown and described in detail. A single dynamicforce strap is effective to unload the knee in a soft dynamic way,however it may tend to cause the brace to rotate around the leg. Somehave designed around that by adding a second dynamic force strap howeverit creates more bulk in the popliteal region and therefore discomfortfor the user as well as an increased complexity of donning and doffing.This Y strap configuration uses a standard dynamic force strap but thena second strap that connects to the dynamic force strap above thepopliteal, spirals around the leg to the thigh shell on the oppositesite of where the dynamic force strap connects to the shell andtherefore resists the rotation forces without creating bulk ordiscomfort in the popliteal region.

An orthopeadic device may include a hinge attached to a thigh shell anda calf shell. Such frame may be attached to a sleeve that includes afirst panel defining opposed first and second sides. A second panel hasa first end secured to the first side of the first panel along a seambetween the upper and lower corners of the seam, and a second enddefining at least one flap securable to the second side of the firstpanel at a location site. A first strap has a first end secured to thefirst side of the first panel below the second panel. A second strap hasa first end secured to the first side of the first panel below thesecond panel and overlays at least a portion of the first strap. Adynamic Y force strap helically extends between the upper and lowerportions of the orthopeadic device and connects to the first panel. Suchstrap splits into a second strap around knee center which spirals in theopposite direction of the first end to attach on the opposite side ofthe first panel. Such an orthopeadic device may contain a heightadjustment mechanism so that the frame could be lengthened or shortenedwithout tools in order to accommodate different leg lengths.

FIGS. 10A-10C show the Y strap configuration using a Velcro connection.The so called half strap that creates the Y can be attached to the soliddynamic force strap using Velcro or any other means of attachment. Inthe current form a semi rigid or rigid plate is attached to the dynamicunloading strap with a keyhole. One end of the short strap may have abutton hook sewn to it so that it may snap with the plate that isattached firmly to the dynamic unloading strap. This allows the shortstrap to pivot and align with the thigh to wrap around and attach to thethigh plate. Both strap ends attach to the thigh plate as can be seen onFIG. 10C. Both straps may be adjusted with a Velcro, Velcro through a Dring, BOA cable mechanism, ratchet, combinations of the foregoing or anyother form of tightening mechanism.

FIGS. 10D and 10E shows how the Y strap can be controlled with a singletensioning mechanism (e.g., a BOA mechanism). In this illustratedconfiguration, a single BOA dial or any other form of a tighteningmechanism may be placed at the location where the strap separates intotwo straps. Cables may be embedded into the fabric of the sleeve or bevisible and attached with guides on the outside of the sleeve.Offloading component may therefore be controlled through tightening of,for example, a single dial and all strap ends may be fixed to the frame(e.g., two at the thigh shell and one on the calf shell). There mayadditionally include an initial adjustment feature on both strap endslocated on the thigh shell to ensure that the straps are adjusted enoughto provide proper and even unloading when the tightening occurs.

FIG. 10F-10H illustrates how the sleeve may be constructed using a wraparound sleeve configuration that includes three to four attachmentsrespectively.

FIG. 10F shows a three tab configuration with a single wide tab at thethigh and two tabs on the calf. Such a configuration may aid the userwith donning of the device, especially on the calf by providing, forexample, a secure elastic suspension strap that is easy for the user topull on. The number of steps required to don the brace may be fewer ascompared to, for example, a four tab design.

FIG. 10G shows a flat view of the three tab configuration with one widethigh flap that connects to the upper calf flap and then a separatelower calf strap which can either sit underneath or above the thigh/calfpanel flaps. This lower calf strap could also be positioned as the uppercalf strap to provide very secure suspension and sit underneath thethigh/calf flap. In that configuration the thigh/calf flap would consistof the thigh flap and the lower calf flap.

In FIG. 10G (an outer flat view), in this configuration the user startsby applying two straps, one above the calf and one on the lower thigh.Then patient applies a wide panel that includes the bottom calfattachment and the top thigh attachment. The two straps sit thereforeunderneath the wide outer panel. Prior to donning the brace fitter canuse pre-determined trim lines shown in order to adjust the brace to theappropriate circumference size for both thigh and calf. Another possiblecircumference adjustment is also through a wide alligator clip that canbe added onto flap to lengthen brace circumference. Fitter can alsoalter the height of the brace by pushing buttons on thigh shell and calfshell that engage with arms on hinge to lengthen or shorten frame bypulling shells away from hinge center or pushing shells towards hingecenter. Sleeve has sufficient vertical elasticity to accommodate thedifferent frame lengths.

FIG. 10H shows the inner flat view of the brace shown in FIG. 10G.

FIG. 10I shows two wraps, where one wrap is applied to a thigh shell andthe other wrap is applied to a calf shell. Both wraps include two strapsrespectively to make sure that the donning is easy and effective intension for the user. This provides a very secure suspension as well ascomfortable compression above and below the joint. Another benefit ofthis system is that the brace frame could contain height adjustment fora short, regular and tall patient. The Y strap shown could also be asimple dynamic force strap without the additional Y strap component.

A similar Y strap configuration could also be applied to the lowersection of the dynamic offloading strap, without the thigh strapcomponent or in conjunction with the thigh component. When both strapswere to be used with the offloading straps, rotational control appliedto both thigh and calf can be accomplished. The two additional strapswould both anchor to the offloading straps close to knee center howeverwould not have to be anchored at the same location. This would allow foroptimal placement of such straps without them having to cross in thepopliteal which is a common issue for a so called double dynamic forcestrap brace. The lower strap section would then go through, for example,a D ring on the calf shell for tightening or adjustment by the patientsimilar to how the dynamic offloading strap is adjusted.

Where certain elements of these implementations can be partially orfully implemented using known components, only those portions of suchknown components that are necessary for an understanding of the presentdisclosure are described, and detailed descriptions of other portions ofsuch known components are omitted so as not to obscure the disclosure.

In the present specification, an implementation showing a singularcomponent should not be considered limiting; rather, the disclosure isintended to encompass other implementations including a plurality of thesame component, and vice-versa, unless explicitly stated otherwiseherein.

Further, the present disclosure encompasses present and future knownequivalents to the components referred to herein by way of illustration.

It will be recognized that while certain aspects of the technology aredescribed in terms of a specific sequence of steps of a method, thesedescriptions are only illustrative of the broader methods of thedisclosure, and may be modified as required by the particularapplication. Certain steps may be rendered unnecessary or optional undercertain circumstances. Additionally, certain steps or functionality maybe added to the disclosed implementations, or the order of performanceof two or more steps permuted. All such variations are considered to beencompassed within the disclosure disclosed and claimed herein.

While the above detailed description has shown, described, and pointedout novel features of the disclosure as applied to variousimplementations, it will be understood that various omissions,substitutions, and changes in the form and details of the device orprocess illustrated may be made by those skilled in the art withoutdeparting from the disclosure. The foregoing description is of the bestmode presently contemplated of carrying out the principles of thedisclosure. This description is in no way meant to be limiting, butrather should be taken as illustrative of the general principles of thetechnology. The scope of the disclosure should be determined withreference to the claims.

What is claimed:
 1. A foot ankle orthoses, comprising: a sock that isconfigured to fit over a calf muscle on a leg of a user; and acompression strap system comprising: an upper retention structure thatis configured to be positioned above the calf muscle of the user whendisposed on the leg of the user, the upper retention structurecomprising a first structure that is spaced circumferentially from asecond structure; an ankle retention structure that is configured to bepositioned around an ankle of the user and below the calf muscle of theuser; a foot retention structure that is configured to be positionedproximate a ball of a foot of a user; and a support element that isoperatively coupled with the first structure, the second structure, theankle retention structure, and the foot retention structure; wherein theupper retention structure is configured to tighten around an anatomy ofthe user when the sock moves into a plantar flexed position viaapplication of tension between the first structure and the secondstructure.
 2. The foot ankle orthoses of claim 1, wherein the ankleretention structure comprises: an upper ankle retention structure thatis configured to be positioned above the ankle of the user and below thecalf muscle of the user; and a lower ankle retention structure that isconfigured to be positioned below the ankle of the user at a transitionpoint between a heel of the user and a midfoot of the user.
 3. The footankle orthoses of claim 1, wherein the support element comprises one ormore of a support strap or a support cable.
 4. The foot ankle orthosesof claim 1, further comprising an adjustable tensioning mechanismdisposed at an upper portion of the sock, the adjustable tensioningmechanism configured to tension the support strap or the support cable.5. The foot ankle orthoses of claim 4, wherein the sock is separablefrom the compression strap system.
 6. The foot ankle orthoses of claim4, wherein the compression strap system is integrated with the sock. 7.The foot ankle orthoses of claim 4, wherein the upper retentionstructure is configured to tighten around an anatomy of the user wheneither: (i) the adjustable tensioning mechanism is tightened and/or (ii)the user's foot goes into plantar flexion.
 8. The foot ankle orthoses ofclaim 7, wherein the upper ankle retention structure and the lower ankleretention structure is configured to tighten around the anatomy of theuser when the adjustable tensioning mechanism is tightened.
 9. The footankle orthoses of claim 8, wherein the foot retention structure isconfigured to place the foot of the user into a neutral to slightdorsiflexion when the adjustable tensioning mechanism is tightened. 10.The foot ankle orthoses of claim 4, wherein the sock includes lowstretch in a horizontal direction at least in a region adjacent to theankle of the user and in a region above the calf muscle of the user ascompared with at least one other region of the sock.
 11. The foot ankleorthoses of claim 4, wherein the support strap or the support cablecomprises a substantially inelastic material.
 12. The foot ankleorthoses of claim 11, wherein the sock comprises one or more layers ofmaterial and the support strap or the support cable is threaded into andout of at least one of the one or more layers of material.
 13. The footankle orthoses of claim 12, wherein one or more of the upper retentionstructure, the upper ankle retention structure, the lower ankleretention structure, and the foot retention structure is disposedinternal to at least one of the one or more layers of material.
 14. Thefoot ankle orthoses of claim 12, wherein the sock comprises two or morelayers of material and the support strap or the support cable isthreaded between at least two of the two or more layers of materialthereby preventing direct contact of the support strap or the supportcable with skin of the user.
 15. The foot ankle orthoses of claim 14,wherein one or more of the upper retention structure, the upper ankleretention structure, the lower ankle retention structure, and the footretention structure is disposed internal to at least one of the two ormore layers of material.
 16. The foot ankle orthoses of claim 12,further comprises a plurality of support strap/cable guides that isconfigured to reduce friction and facilitate movement of the supportstrap or the support cable.
 17. The foot ankle orthoses of claim 12,further comprising a reinforced structure disposed on a top portion ofthe foot of the user, the reinforced structure configured to preventover tensioning of the support strap or the support cable in a region ofthe foot of the user.
 18. A method for using a foot ankle orthoses, themethod comprising: placing a sock onto a leg of a user; pulling a topportion of the sock over a calf muscle on the leg of the user; andadjusting tension of a compression strap system of the sock, theadjusting of the tension of the compression strap system comprisessimultaneously: adjusting of tension between a first structure that iscircumferentially spaced from a second structure, the first structureand the second structure being disposed on an upper retention structure;and adjusting tension between the upper retention structure and a footretention structure.
 19. The method of claim 18, wherein the pulling ofthe top portion of the sock over the calf muscle on the leg of the usercomprises pulling the upper retention structure over the calf muscle onthe leg of the user.
 20. The method of claim 19, wherein the adjustingof the tension of the compression strap system comprises rotating arotary tensioning mechanism in order to adjust tension of a supportstrap or a support cable that is operatively coupled with the upperretention structure, an ankle retention structure, and the footretention structure.